![]() MECART has made every reasonable effort to ensure the accuracy of all the information contained in this document. The views and opinions expressed herein constitute the judgment of the authors and are subject to change without notice. The information, statements, opinions and analyses provided by MECART in this document is designed to provide helpful and educational information on the subjects discussed. Other regional and local regulations may apply. Constructing a rated-shaft enclosure around a duct can add significant cost to a project. When a hazardous exhaust duct penetrates a rated area, the duct requires enclosures in a fire-resistant rated shaft. Routing the hazardous exhaust throughout the existent facility sometimes includes passing HD ducts through rated fire and smoke walls. The HD exhaust system must lead to a roof-mounted fan location discharging at a minimum of 10 feet above the roof level and 30 feet away from fresh air intakes (standard distances – please check your local building code). Hence, exterior exhaust is a tricky, and potentially costly and complicated, aspect of a USP-800 compliant compounding facility. For example, for pharmacies on the lower floor of a multiple story building, it can easily become a headache to find the optimal way to get the air outside on the roof. In theory, it might look simple but depending on the location of the compounding facility within a building, this is sometimes very complex. Negative pressure is achieved by drawing air out of the room by means of an exhaust fan (as opposed to blowing air in with a supply fan).Īnother important aspect of USP-800-compliant facilities is that the air must be evacuated outside (no recirculation). It might seem contradictory to build a sterile ISO 7 room under negative pressure, as negative pressure pulls air particles towards the inside of the room, while ISO 7 compliance requires the room to be free of particles, however, the physics works and this is why it is so important that the HVAC system be designed correctly. To counter cross-contamination of adjacent areas, instead of the air leaking towards the outside of the room (positive pressure), the negative pressure pulls the air towards the inside of the room, in the exhaust of the C-PEC (such as a BSC) and the low air returns of the C-SEC (buffer zone). ![]() The main difference between USP-797 and the compounding of hazardous drugs under USP-800 is the negative pressure requirement which aims to protect both workers and any environment which comes into contact with potential hazards. ![]() > You might also like this article: Starting a Sterile Compounding Pharmacy Get a Quote National, regional, and local standards and regulations may also apply in addition to USP-800. In our text, we offer our interpretation of the standards based on our experience. Please note there is no “one size fits all” answer and there are still some undefined details in USP-800, which leaves room for discussion and interpretation. In this article, you will find a basic overview of the aspects of USP-800 with a focus on the facility itself (the shell and the HVAC air treatment system). This extra time is crucial as building a facility for hazardous drug (HD) compounding is much more complex than for non-HD sterile compounding (USP-797), and will give pharmacies more time to comply with the USP 800 cleanroom requirements. Although initially set to go into effect July 1, 2018, USP has announced it is postponing the official date for the application of USP-800 to December 1, 2019. We hear more and more about USP-800, the new chapter of compounding standards for safe handling of hazardous drugs.
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